MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE Tuohy; Tuohy_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	1150-6M091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This incident took place in usa.The device subject to the claim has been requested for analysis.Investigations are ongoing.Final evaluation is being transmitted in final report.
Event or Problem Description
(b)(4).This incident took place in usa.Reaching out to share that we had an issue with an epidural needle today.During an insert the stylet snapped off at the hub, and the stylet was lodged within the needle.Fortunately, the needle was removed from the patient's back and the stylet remained within the needle.I have the needle and lot # on hand.Aside from requiring a second insertion attempt, there were no further complications for this patient.Second attempt to reinsert a new needle with stylet successful.The patient is doing well; the complete needle with stylet was successfully removed in its entirety.
Event or Problem Description
Irn#(b)(4) this incident took place in usa.Reaching out to share that we had an issue with an epidural needle today.During an insert the stylet snapped off at the hub, and the stylet was lodged within the needle.Fortunately, the needle was removed from the patient's back and the stylet remained within the needle.I have the needle and lot # on hand.Aside from requiring a second insertion attempt, there were no further complications for this patient.Second attempt to reinsert a new needle with stylet successful.The patient is doing well; the complete needle with stylet was successfully removed in its entirety.
Additional Manufacturer Narrative
Irn#(b)(4) this incident took place in usa.Following the final assessment, the item in question was corrected to reference number 1150-6m091.This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: Tuohy
• Common Device Name: Tuohy_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GmbH Medizintechnologie; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• MDR Report Key: 25826486
• Report Number: 9611612-2026-00015
• Device Sequence Number: 16048060
• Product Code: BSP
• UDI-Device Identifier: 04048223130421
• UDI-Public: 04048223130421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1150-6M091
• Device Lot Number: 02500013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown